Hesperidin

Compositional guideline for 'Hesperidin' permitted for use in listed medicines

Last updated

15 July 2013

Name of the ingredient

Hesperidin (AAN)

(S)-7-[[6-O-(6-Deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-2,3-dihydro-4H-1-benzopyran-4-one

Molecular formula: C₂₈H₃₄O₁₅

Molecular mass: 610.56

CAS Number: 520-26-3

Table 1: Ingredient specific requirements
Test	Method reference	Acceptance criteria
Description
Appearance	Visual	Pale yellow - yellow green crystalline, hygroscopic powder
Characteristics
Solubility	BP (General notice)	Slightly soluble in water and methanol, soluble in solutions of alkali hydroxides
Melting point	BP (Appendix V A)	258-262°C
Optical rotation	BP (Appendix V F)	-74° to -78° (in pyridine), calculated with reference to the dried substance
Water (determined on 0.100g)	BP (Appendix IX C, method 1)	Not more than 5.0% w/w
Identification
IR	BP (Appendix II A)	Spectrum matches that of the authenticated reference material
Assay
Hesperidin	HPLC	98.0-102.0% (anhydrous basis)

Table 2: Incidental constituents
Test	Method reference	Acceptance criteria
Residual solvents
Residual solvents	BP (Appendix VIII L)	Complies
Incidental metals and non-metals
Heavy metals (as lead)	BP (Appendix VII)	Not more than 10 ppm
Other organic or inorganic impurities or toxins
Sulfated ash	BP (Appendix IX A)	Not more than 0.4%
Related substances	HPLC	Not more than 1.0% for oxedrine or any other individual impurity, and not more than 2.0% for total impurities
Microbiology
While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product that contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order.

BP = British Pharmacopoeia

HPLC = High-pressure liquid chromatography

IR = Infrared spectrophotometry

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